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calendar

1,561 catalysts · 4,728 grant · 3,288 8k filing · 2,654 approval · 2,246 device 510k · 1,812 device recall · 1,561 device pma

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 0 catalysts2026-08-13: 118 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 3 catalysts2026-08-20: 0 catalysts2026-08-21: 0 catalysts2026-08-22: 0 catalysts2026-08-23: 0 catalysts2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 0 catalysts2026-09-05: 0 catalysts2026-09-06: 0 catalysts2026-09-07: 0 catalysts2026-09-08: 0 catalysts2026-09-09: 0 catalysts2026-09-10: 0 catalysts2026-09-11: 0 catalysts2026-09-12: 0 catalysts2026-09-13: 0 catalysts2026-09-14: 0 catalysts2026-09-15: 0 catalysts2026-09-16: 0 catalysts2026-09-17: 0 catalysts2026-09-18: 0 catalysts2026-09-19: 0 catalysts2026-09-20: 0 catalysts2026-09-21: 0 catalysts2026-09-22: 0 catalysts2026-09-23: 2 catalysts2026-09-24: 0 catalysts2026-09-25: 0 catalysts2026-09-26: 0 catalysts2026-09-27: 0 catalysts2026-09-28: 0 catalysts2026-09-29: 0 catalysts2026-09-30: 0 catalysts2026-10-01: 0 catalysts2026-10-02: 0 catalysts2026-10-03: 0 catalysts2026-10-04: 0 catalysts2026-10-05: 0 catalysts2026-10-06: 0 catalysts2026-10-07: 0 catalysts2026-10-08: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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type: device pma×from 2025-07-29×clear all
type
  • grant4,728
  • 8k filing3,288
  • approval2,654
  • device 510k2,246
  • device recall1,812
  • device pma1,561
device adverse event
1,000
  • recall600
  • earnings584
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jul 28, 2025

    25
    ›Jul 29, 2025device pma381d agoABBOTT MEDICAL — Epic™ Plus Stented Tissue Valve; Epic™ Max Stented Tissue Valve (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jul 29, 2025device pma381d agoABBOTT MEDICAL — Tendyne™ Transcatheter Mitral Valve (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NPU. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jul 29, 2025device pma381d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG (SED01); Adapta, Versa, Sensia IPG (ADSR01, VEDR01); Adapta, Versa, Sensia IPG (ADVDD01); Adap (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jul 29, 2025device pma381d agoMedtronic, Inc. — MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: PNJ. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jul 29, 2025device pma381d agoMedtronic Neuromodulation — Model A71100 Restore Clinician Programmer Application (CPA) and Model A71200 Vanta™/Sequentia™ LT Clinician Programmer A (PMA supplement)

    Supplement type: Real-Time Process. Product code: LGW. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Jul 29, 2025device pma381d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jul 29, 2025device pma381d agoABBOTT MEDICAL — Navitor™ Transcatheter Aortic Valve (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NPT. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jul 29, 2025device pma381d agoMedtronic, Inc. — Aurora EV-ICD System (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jul 29, 2025device pma381d agoMedtronic Cardiac Rhythm Disease Management — Evera MRI DF-1 ICD (DDMB1D1, DVMB1D1, DVMC3D1); Evera MRI DF-1 ICD(DDMC3D1); Evera MRI ICD (DDMB1D4); Evera MRI ICD (DDM (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jul 30, 2025device pma380d agoCooperVision, Inc. — MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (PMA supplement)

    Supplement type: 30-Day Notice. Product code: QIT. Advisory committee: OP. Decision: OK30

    full page →fda device pma ↗
    ›Jul 30, 2025device pma380d agoSetPoint Medical — SetPoint System (PMA)

    Product code: SFJ. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Jul 30, 2025device pma380d agoCentinel Spine, LLC — prodisc L (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MJO. Advisory committee: OR. Decision: OK30

    full page →fda device pma ↗
    ›Jul 30, 2025device pma380d agoBausch & Lomb, Inc. — enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL) (PMA supplement)Bausch & Lomb Corp

    Supplement type: 135 Review Track For 30-Day Notice. Product code: MFK. Advisory committee: OP. Decision: APPR

    full page →fda device pma ↗
    ›Jul 30, 2025device pma380d agoVascutek, Ltd. — Thoraflex™ Hybrid (PMA supplement)

    Supplement type: 30-Day Notice. Product code: QSK. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jul 30, 2025device pma380d agoCentinel Spine, LLC — prodisc® C (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MJO. Advisory committee: OR. Decision: OK30

    full page →fda device pma ↗
    ›Jul 31, 2025device pma379d agoThe Cooper Companies — Biomedics 55 Asphere; Biomedics Toric (PMA supplement)COOPER COMPANIES, INC.

    Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30

    full page →fda device pma ↗
    ›Jul 31, 2025device pma379d agoVentana Medical Systems, Inc. — CINtec PLUS Cytology (PMA supplement)MERIT MEDICAL SYSTEMS INC

    Supplement type: Real-Time Process. Product code: QKF. Advisory committee: PA. Decision: APPR

    full page →fda device pma ↗
    ›Aug 1, 2025device pma378d agoAbiomed, Inc. — Impella 5.5 with SmartAssist System; Impella CP with SmartAssist System; Impella 2.5; Impella 5.0; Impella LD; (PMA supplement)Abion Inc

    Supplement type: Normal 180 Day Track No User Fee. Product code: OZD. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Aug 1, 2025device pma378d agoAbiomed, Inc. — Impella RP System; Impella RP with SmartAssist System; Impella RP Flex with SmartAssist System; (PMA supplement)Abion Inc

    Supplement type: Normal 180 Day Track No User Fee. Product code: PYX. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Aug 1, 2025device pma378d agoMedtronic, Inc. — AFR-00004 HexaGen RF Generator (RFG) and AFR-00008 HexaPulse PF Generator (PFG) (PMA supplement)Medtronic plc

    Supplement type: Real-Time Process. Product code: QZI. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Aug 1, 2025device pma378d agoDePuy Orthopaedics, Inc. — CERAMAX CERAMIC HIP SYSTEM (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MRA. Advisory committee: OR. Decision: OK30

    full page →fda device pma ↗
    ›Aug 1, 2025device pma378d agoMedtronic Neuromodulation — InterStim™ Therapy System, Verify™ Evaluation System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30

    full page →fda device pma ↗
    ›Aug 1, 2025device pma378d agoABBOTT MEDICAL — TactiFlex™ Ablation Catheter, Sensor Enabled™ (PMA supplement)

    Supplement type: Real-Time Process. Product code: OAE. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Aug 1, 2025device pma378d agoBoston Scientific Corp — AngioJet Thrombectomy System (PMA supplement)BOSTON SCIENTIFIC CORP

    Supplement type: 30-Day Notice. Product code: MCX. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 1, 2025device pma378d agoMedtronic Neuromodulation — InterStim™ Therapy System, Verify™ Evaluation System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30

    full page →fda device pma ↗

    Week of Aug 4, 2025

    25
    ›Aug 4, 2025device pma375d agoAcu Focus, Inc. — IC-8 Apthera Intraocular Lens (IOL) (PMA supplement)

    Supplement type: Special (Immediate Track). Product code: POE. Advisory committee: OP. Decision: APPR

    full page →fda device pma ↗
    ›Aug 4, 2025device pma
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    page 1 of 32
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    375d ago
    Oxford Immunotec, Ltd. — T-SPOT.TB TEST (PMA supplement)

    Supplement type: Real-Time Process. Product code: OJN. Advisory committee: MI. Decision: APPR

    full page →fda device pma ↗
    ›Aug 4, 2025device pma375d agoABBOTT MEDICAL — Avant (CDHFA700Q, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800T CDHFA600Q, CDHFA600T); Gallant (CDHFA500Q, CDHFA500T); (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 4, 2025device pma375d agoSiemens Healthcare Diagnostics Products, Ltd. — IMMULITE 2000 Systems Total Antibodies to Hepatitis B Core Antigen (Anti-HBc) (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LOM. Advisory committee: MI. Decision: OK30

    full page →fda device pma ↗
    ›Aug 4, 2025device pma375d agoABBOTT MEDICAL — Avant™ VR (CDVRA700Q, CDVRA700T); Neutrino™ NxT VR (CDVRA800Q, CDVRA800T CDVRA600Q, CDVRA600T); Gallant™ VR (CDVRA500Q, (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 4, 2025device pma375d agoAgilent Technologies, Inc. — PD-L1 IHC 22C3 pharmDx (Dako Omnis) (PMA supplement)AGILENT TECHNOLOGIES, INC.

    Supplement type: Normal 180 Day Track. Product code: PLS. Advisory committee: PA. Decision: APPR

    full page →fda device pma ↗
    ›Aug 4, 2025device pma375d agoOxford Immunotec, Ltd. — T-SPOT.TB Test (PMA supplement)

    Supplement type: 30-Day Notice. Product code: OJN. Advisory committee: MI. Decision: OK30

    full page →fda device pma ↗
    ›Aug 5, 2025device pma374d agoInstylla, Inc. — Embrace(TM) Hydrogel Embolic System (PMA)

    Product code: QVG. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Aug 5, 2025device pma374d agoDePuy Orthopaedics, Inc. — CERAMAX CERAMIC HIP SYSTEM (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MRA. Advisory committee: OR. Decision: OK30

    full page →fda device pma ↗
    ›Aug 5, 2025device pma374d agoTerumo Medical Corporation — MISAGO® RX Self-expanding Peripheral Stent; R2P Misago RX Self-expanding Peripheral Stent System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 5, 2025device pma374d agoMedtronic Vascular, Inc. — EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: NIP. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Aug 5, 2025device pma374d agoDepuy, Inc. — LCS® Total Knee System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NJL. Advisory committee: OR. Decision: OK30

    full page →fda device pma ↗
    ›Aug 5, 2025device pma374d agoSirtex Medical, Inc. — Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit (PMA supplement)

    Supplement type: Real-Time Process. Product code: QVG. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Aug 5, 2025device pma374d agoAbbott Molecular, Inc. — Vysis ALK Break Apart FISH Probe Kit (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: OWE. Advisory committee: PA. Decision: APPR

    full page →fda device pma ↗
    ›Aug 5, 2025device pma374d agoSmith & Nephew, Inc. — ASCENSION MCP (PMA supplement)SMITH & NEPHEW PLC

    Supplement type: 30-Day Notice. Product code: NEG. Advisory committee: OR. Decision: OK30

    full page →fda device pma ↗
    ›Aug 5, 2025device pma374d agoTeleflex Medical, LLC — MANTA™ Vascular Closure Device; MANTA Vascular Closure Device, 18F; MANTA Vascular Closure Device, 14F; MANTA SF Depth L (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MGB. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 6, 2025device pma373d agoMedtronic Neuromodulation — InterStim™ Therapy System, Verify™ Evaluation System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30

    full page →fda device pma ↗
    ›Aug 6, 2025device pma373d agoMedtronic, Inc. — Consulta CRT-P (C4TR01); Syncra CRT-P (C2TR01) (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 6, 2025device pma373d agoMedtronic Neuromodulation — InterStim™ Therapy System, Verify™ Evaluation System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30

    full page →fda device pma ↗
    ›Aug 6, 2025device pma373d agoMentor Corp. — Mentor MemoryGel® Breast Implants (PMA supplement)

    Supplement type: 135 Review Track For 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Aug 6, 2025device pma373d agoMedtronic, Inc. — Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30

    full page →fda device pma ↗
    ›Aug 6, 2025device pma373d agoMedtronic Neuromodulation — Master Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30

    full page →fda device pma ↗
    ›Aug 6, 2025device pma373d agoMedtronic Minimed, Inc. — Simplera Sync Sensor, Guardian 4 Sensor (PMA)Medtronic USA Inc

    Product code: SFI. Advisory committee: CH. Decision: APPR

    full page →fda device pma ↗
    ›Aug 6, 2025device pma373d agoCochlear Americas — Nucleus® 24 Cochlear Implant System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MCM. Advisory committee: EN. Decision: OK30

    full page →fda device pma ↗
    ›Aug 6, 2025device pma373d agoMedtronic, Inc. — Advisa DR IPG (A4DR01); Advisa DR MRI IPG (A2DR01); Advisa SR MRI IPG (A3SR01) (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    $BSX51.39-0.07%
    $MDT90.58-0.20%
    $COO
    $MDT90.58-0.20%
    $MDT90.58-0.20%
    $MMSI90.50-0.77%
    $BLCO16.89+0.78%
    $MDT90.58-0.20%
    $A148.56+0.22%
    $SNN30.00+0.55%
    $MDT90.58-0.20%
    $MDT90.58-0.20%
    $MDT90.58-0.20%